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Presenters: Raj Kishor [CRC] Tech Observer India Pvt.ltd New Delhi, India

ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

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Page 1: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

Presenters: Raj Kishor [CRC] Tech Observer India Pvt.ltd New Delhi, India

Page 2: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

CONTENTs Introduction. History Of ICMR. Review Systems Of ICMR. Challenges of ICMR Achievements in Drugs & Vaccines. IEC related Activities. ICMR Centers. ICMR Guidelines. Conclusion. Reference.

Page 3: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

INTRODUCTIONType Professional

Organization

Head Quarters New Delhi

Secretary & Director General

Dr. Vishwa Mohan Katoch

Page 4: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

The Govt. of India set up the Indian Research Fund Association (IRFA).

Objective was Sponsoring and Coordinating Medical Research in the Country.

IRFA is Redesignated into Indian Council Of Medical Research.

Page 5: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

REVIEWING SYSTEM OF

ICMRGovt. BodyPresident

Union Minister of Health & Family WelfareGovt. of INDIA

Review Committee Executive Committee

Scientific Advisory Board

Scientific Advisory Group

Extramural Research Intramural Research

ExpertGroup

ResearchFellowship

Project ReviewCommittee onSpecific Topic

Adoch ResearchScheme

Task Force

Study Group

Steering Committee

Multicentric Projects

Scientific AdvisoryCommittee

Centers of Advanced Research

Scientific AdvisoryCommittee

ICMR ResearchInstitutes/Centers

Page 6: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

ICMR ACTIVITIES

1.CommunicableDisease

2.Non-CommunicableDisease

3.Reproductive and Child Health

4.Nutrition

Page 7: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

Communicable Disease:-New Registries Repository

Investigation Of Outbreaks

Promising Leads

-Clinical trial registry of INDIA launched in JULY 2007, 150 trials registered.-A repository of leishmania isolate started at RMRI,PATNA.

-Confirmatory diagnostic tests for H1N1 flu virus.-Acute haemorrhagic conjunctivities outbreak in Mumbai, coxsackie virus A24v was incriminated.-Chikungunya outbreaks investigated in several states viz. Kerala, Tamil Nadu, Andaman islands, etc.

-Novel drug efflux protein of M.tuberculosis as potential therapeutic/diagnostic targets.-New proteins of M.leprae as potential therapeutic target.-Three trial transfer of tibialis posterior muscle to reconstruct foot-drop.-A process for preparation of Cyclosporin A.

Page 8: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

Non-Communicable Diseases:-Oncology Diabetes Non-Communicable

disease surveillance

-Twenty three population based and five hospital based cancer registries functioning under the National Cancer Registry Programme (NCRP).

-Launched registry of people with Diabetes with young age at onset with 8 centers with aim to understand magnitude of problem, disease pattern or type including the geographic variation and incidence and prevalence rate of complications.

-In P-I of the surveys, data on major NCD risk factors has been collected in the urban and the rural subjects aged 15-64 yrs in 7 states of the country.-The work of updating the risk factor infobase with newer publications is progressing.

Page 9: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

Reproductive and Child Health:-

Women’s Health:Intra uterine

contraceptive device is

introduced

Basic Reproductive Biology:

Identification of Mannose Receptor

for CD4 independent

responsible for ST HIV

Infertility:ICMR/NAMS developed

guidelines for ART for accreditation, supervision and

regulation.

Child Health:Oral

Amoxicillin(3days) Vs Oral

Trimoxazole(5days) in children for non severe pneumonia

demonstrated.

Animal Facilities for Research:

National Center for primate breeding and research has

been established in Mumbai.

Page 10: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

Nutrition:-

Food and Drug Toxicology:-Safety evaluation of traditional medicine.

-Assessment of street foods.

Nutrition Education and Communication:-Study on coverage of nutrition related topic in print media.

-Case studies on Institutional approaches to nutrition communication.

Page 11: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

CURRENT ACTIVITY: (19-FEB-2013) The INDIA and

SOUTH ASIA specific finding were released jointly by Center for Science and Environment(CSE), ICMR and The U.S based Health effects Institute.

Stroke(25.48

%)

Pulmona--ry

disease (17.32%

)

Heart disease(48.6%)

Respirat-ory

infection(6.4%)

Lung cancer (2.02%)

Global burden of disease report.

Page 12: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

ACHIEVEMETS IN DRUGS &

VACCINESDRUGS:- Completed Phase-II expanded safety and acceptability

study of vaginal microbicide 1% Tenofovir gel-100% retention rate.Overall safety profile of product was gud. Five Clinical Trials with new artemisinin combinations successfully completed for Malaria. Combination Therapies for visceral Leishmaniasis evaluated (Ambisome, Miltofosine and Paramomycin). Efficacy and Safety of 3 and 4 months Moxiflox containing regimen for Pulmonary TB are underway. Efficacy of Combined Immunotherapy and Chemotherapy in Pulmonary Tuberculosis is being evaluated.

Page 13: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

VACCINES:- Two Phase-I studies for HIV vaccines were completed, AAV at NARI Pune and MVA based vaccine at TRC, Chennai. Conducted Phase-III trial of Rotavirus vaccine. Phase-II trial of bivalent killed whole cell oral Cholera vaccine VA 1.3 completed. Phase-III launched. Phase-I of 3 site measles aerosol vaccines completed. Found to be safe and immunogenic. A Recombinant protein based vaccine for Chandipura developed. Combination of this vaccine with DPT found to be stable in animal experiments. Development of combined Hep E and B vaccines are under progress. A Recombinant protein based, highly specific and sensitive assay for the diagnosis of Hepatitis E developed.

Page 14: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

IEC RELATED ACTIVITIES

ICMR-WHO survey of Institutional Ethics Committee was done to examine the functioning of Ethics Committee. ICMR’s Central Ethics Committee on Human Research (CECHR) examines proposals of National relevance or National significance and also Ethical Issues which are brought to its notice by the Institutional Ethics Committees or Govt. Departments.

Page 15: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

ICMR CENTERS National Institute of Virology (NIV), PUNE. National Institute of Nutrition (NIN), HYDERABAD. National Center for Laboratory Animal Science (NCLAS), HYDERABAD. Food and Drug Toxicology Research Center (FDTRC), HYDERABAD. National Institute of Malaria Research (NIMR), DELHI. National Institute for Research in Reproductive Health (NIRRH), MUMBAI. Tuberculosis Research Center (TRC), CHENNAI. National Institute of Epidemiology (NIE), CHENNAI. National Institute of Medical Statistics (NIMS), DELHI. National Institute of Cholera & Enteric Diseases (NICED), Kolkata.

Page 16: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

ICMR CENTERS (Cont.)

National Institute of Immunohaematology (NII), MUMBAI. Enterovirus Research Center (ERC), MUMBAI. Genetic Research Center (GRC), MUMBAI. Institute of Cytology and Preventive Oncology (ICPO), NOIDA. Institute of Pathology (IOP), DELHI.

Page 17: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

Permanent Institutes/ Centers

Regional Medical Research Centre

Delhi (4) Belgaum (1)

Mumbai (4) Jodhpur (1)

Hyderabad (3) Jabalpur (1)

Chennai (2) Bhubaneswar (1)

Pune (2) Dibrugarh (1)

Pondicherry (1) Port Blair (1)

Madurai (1)

Ahmedabad (1)

Agra (1)

Patna (1)

Kolkata (1)

Page 18: ICMR Guidelines Presented By:Raj Kishor [CRC], Tech Observer the Global CRO,India

TO BE CONTINUE……….